Apparatus, system, and method for the objective evaluation of corporeal pain

ABSTRACT

Various methods and machines have been used in the past to measure electrical characteristics of living tissue for purpose of locating an area of abnormal nervous system activity. However, whereas prior art methodologies merely allow for the detection of pain, the apparatus, system and method of the present invention allow for the objective assessment pain severity that finds utility not only the initial diagnosis but also the on-going treatment of any disease, disorder or injury associated therewith. To that end, the apparatus, system and method of the present invention allows medical practitioners to non-invasively and quantitatively distinguish organic pain from psychosomatic pain and legitimate pain patients from drug seekers and opiod addicts, as well as to directly and objectively compare the efficacy of different drug regimens and therapy protocols.

PRIORITY

This application claims the benefit of U.S. Provisional Application Ser.No. 62/434,169 filed Dec. 14, 2016, the contents of which are herebyincorporated by reference in their entirety.

TECHNICAL FIELD OF THE INVENTION

The present invention relates generally to the correlation betweenelectrical tissue parameters, such as skin conductance, with sympatheticand parasympathetic nerve function (and dysfunction). More particularly,the present invention relates to an apparatus, system and method for thenon-invasive sudomotor assessment of corporeal pain that allows for theobjective measurement of pain severity that, in turn, finds utility notonly in the diagnosis and treatment of any underlying disorder, diseaseor injury associated with the measured pain levels but also indetermining the appropriate drug and dosage regimen, in distinguishingorganic pain from psychosomatic pain and legitimate pain patients fromdrug seekers and opiod addicts, and in directly and objectivelycomparing the efficacy of different therapy protocols and drug regimen.

BACKGROUND OF THE INVENTION

During the latter portion of the twentieth century, researchers madesignificant contributions to the measurement of perspiration and itsrelationship to the sympathetic portions of the human nervous system. Itis accepted that moist skin is associated with the ability to conductelectricity more readily than dry skin, the former having a lowerresistance to electrical flow. When the nerve supply to the skin isinterrupted, skin moisture drops, conductance falls, and the skinresistance level rises.

Early investigations of the variability of skin electrical responsescreated by changing parameters of stimulation indicated that themeasurement of conductance levels, not responses, would provide morestable results. This removed the need for any external or internalstimulation and thus created an improvement in methodology.

Although this technology was originally intended for the measurement ofhuman skin conductance, such electrical assessment has also been usedfor other types of deep tissue, e.g. in the fields of marine biology andplant physiology. Therefore the term Selective Tissue Conductance (STC)was adopted as being more appropriate for the broad range of biologicalmaterials that could be evaluated with this technology.

There are also two other methodological differences that separateSelective Tissue Conductance technology from other forms of skinconductance measurement, namely Spatial Selectivity and TemporalSelectivity.

Early methods of measuring skin conductance or resistance oftenconsisted of passing an electrical test current between a staticreference electrode and a roving or exploring electrode which was movedover the areas of the skin to be assessed. If it happened that thereference and roving electrodes were placed on opposite sides of thebody, then the electrical flow would transverse the body creatingtranscorporeal currents. If this path flowed through electricallysensitive organs, e.g. the heart, theoretical if not actual risks ofarrhythmia would be increased.

In U.S. Pat. No. 4,697,599, the details of which are hereby incorporatedby reference, Woodley et al. discloses a selective tissue conductancemeter that overcomes the problem of spatial selectivity by using afixed, bipolar concentric electrode that is simply pressed against theskin surface. The concentric electrode disclosed in the '599 patentconsists of a center contacting electrode and an outer ring electrodewhich surrounds the center electrode. Additionally, a circular gapfilled with an electrical insulating material is provided between thecenter electrode and the outer ring electrode. Consequently, when theconcentric electrode is pressed against the skin and an electrical testcurrent is discharged from the center electrode, the path of theelectrical test current is restricted so that the test current travelsfrom the center contact electrode to the outer ring electrode by volumeconduction through only the superficial layers of the skin, thuspreventing the possibility of producing a trans-corporeal current.

More specifically, the device disclosed in the '599 patent is adiagnostic device capable of measuring the conductance of human oranimal tissue which includes a housing capable of being held in one handby the user of the device and a concentric electrode mounted on theexterior of the housing. An electric circuit is located in the housingand is connected to the concentric electrode for producing an electricalsignal having a pulse frequency that varies directly according to theconductance of the human or animal tissue placed in contact with theelectrode. The electric circuit includes a voltage to frequencyconverter having an oscillator with logarithmic output so that the pulsefrequency varies logarithmically according to the conductance measuredby the electrodes. The logarithmic output permits a wide range of tissueconductance to be measured. A source of low voltage power is connectedto the circuit and a detector is provided for detecting the electricalsignal to permit the user to know the pulse frequency of the signal.

Almost ten years later, in U.S. Pat. No. 5,897,505, Feinberg et al.describe an improvement on the Woodley construction, wherein theselective tissue conductance apparatus is modified to include athermography sensor. However, while the prior art enables identificationof the presence of pain in one or more certain locations, it fails toenable the automated measurement and objective assessment of the degreeof the pain and thus the severity of the underlying injury, disease ordisorder. Thus, there is a need in the art and the present inventionaims for an apparatus, system, and method for the objective evaluationof corporeal pain.

SUMMARY OF THE INVENTION

A primary goal of the present invention is to provide an apparatus,system and method that allows for the objective evaluation andassessment of patient/subject pain, which, in turn, can be used toidentify and characterize the underlying injury, disease or disorder anddetermine an appropriate therapy, including the adjustment, addition orelimination of chemical, electrical, or physical therapeutic devices

Illustrative aspects and embodiments of the present invention inaccordance with the foregoing objective are as follows:

One objective of the present invention is to provide a hand-held,low-voltage, cost effective diagnostic device for measuring selectivetissue conductance, and optionally other physiological parameters, forthe sympathetic sudomotor assessment of corporeal pain that addressesone or more art-recognized problems and/or drawbacks of prior artalternatives. To that end, in the context of the present invention, thediagnostic device is generally characterized by a sensor head andassociated device housing, wherein the sensor head includes, at aminimum, a pair of spaced electrodes (i.e., a bipolar electrodeassembly) that may be applied to the skin to measure and quantify thelevel of conductance therein, and the device housing contains therequisite power and circuitry components to enable activation of the oneor more sensor head components and transduction of their respectivesignals to an output that may be correlated to pain, abnormal sensation,or sympathetic nerve dysfunction.

Prior art instruments that utilize a fixed electrode require the user touse great care in accurately placing the instrument against thepatient's skin to assure proper uniform contact. This requires that theinstrument always be perpendicular to the surface of the skin.Consequently, if not aligned properly, the instrument will provide anerroneous reading. Moreover, ensuring that the instrument is properlyaligned when placing the electrode on parts of the body that are curvedor contoured, or in places difficult to reach, is particularlyproblematic. Thus, to address alignment problems present in certainprior art alternatives, it is an object of the present invention toprovide the hand-held, low-voltage diagnostic device of the presentinvention with an optional flexible coupling connecting sensor head todevice housing. In preferred embodiments, this coupling may take theform of an articulated, pivoting base for mounting the sensor head tothe device housing. For example, the device may include aball-and-socket type coupling that allows the base of the sensor head topivot and/or rotate freely to assure proper uniform tissue contact. Inone preferred embodiment, the base is provided with a curved or balltype surface that is pivotably received in a mating socket provided onthe distal neck portion of the device housing. In an alternate preferredembodiment, the coupling components are reversed. In either case, thefree pivoting movement causes the sensor head to automatically move intoa properly aligned perpendicular orientation when placed against theskin.

Prior art instruments that utilize permanently installed sensor headscan be problematic as, during use, the permanent electrode can becomecontaminated with skin oils, moisture, or other contaminates that caseerrors in the skin conductance measurements. In addition, some clinicalprocedures require cleaning and disinfecting of the electrodes prior touse on the patient. Cleaning and disinfecting using normal aqueous oralcohol base solutions add additional surface conductivity unless theelectrode is properly dried to remove the residual moisture (which alsocan cause erroneous measurements). Accordingly, to address the drawbacksof the permanently installed sensor head, it is an object of the presentinvention to manufacture the sensor head as a replaceable, detachablebiopolar electrode assembly of sufficiently low cost that may be usedeither as an interchangeable electrode (allowing for propersterilization and drying). Alternatively, the sensor head may bemanufactured as a disposable product.

In certain embodiments of the present invention, the sensor head can bereadily and securely attached to (and detached from) the device housingwith each procedure and/or test subject, for example via a screw-in typemounting with spring loaded contact pins to complete the measurementcircuit. Alternatively, the present invention contemplates a sensor headthat can be physically separated from the device housing, therebyallowing it to be worn by a test subject over a period of time andconfigured for single and/or continuous monitoring and measurement. Inthis latter embodiment, the sensor is optionally provided with means torecord measurements, such as an integral or on-board memory chip ormemory card, and/or means to transmit recorded measurements to thehand-held housing, or, alternatively, directly to a local or remotecomputer system, database or physician. It may further be optionallyconfigured to directly or indirectly coordinate with or connect to oneor more preset ports on a standard laptop computer, smartphone, ortablet.

Many selective tissue conductance meters of the prior art use a direct(DC) current method wherein a small DC voltage is applied between theouter ring and center core of the concentric bipolar electrode assembly.As noted above, the amount of current measured between the two parts ofthe electrode is proportional to the skin conductivity. However, aproblem with the DC current method is that, as the DC potential isapplied to the skin or other body tissue, an ionophoresis effect isproduced in which the current flow between the electrodes increases overtime, thus producing progressively increased measurement values basedupon the duration of the application of the DC currently. Consequently,in the context of DC-based measurements, controlling the time intervalis critical for obtaining consistent results. However, the presentinvention eliminates this problem in certain preferred embodiments byutilizing alternating current (AC), more particularly a high frequency(1 to 100 kHz) AC signal to measure the current between the respectivecomponents of the bipolar electrode assembly. This eliminates theionophoresis effect caused by the use of a DC current. Accordingly, inthe context of the present invention, time of measurement is not acritical variable and thus measurements obtained are more consistent andaccurate.

One objective of the present invention is to provide a multifunctionaldiagnostic device in which the sensor head is outfitted with multiplesensors for measuring multiple physiological parameters. For example, inone preferred embodiment, the sensor head and/or device housingoptionally include other sensors such as (a) thermography cameras andoptical infrared scanners to assess the heat and temperature of theaffected region; (b) sweat-based glucose, lactate and theophyllinebiosensors that enable non-invasive transdermal scoring of analyteconcentration in tissue, particularly muscle tissue; (c) pulse-oximetersto allows for measurement of oxygen saturation levels and assess pre-and post-flow to the affected region; (d) ultrasonic sensors andtransducers that allow a medical practitioner to assess viability andrecovery of muscle tissue.

In certain embodiments, the device housing may outfitted with liquidcrystal display and optionally an onboard microprocessor and/or memorycard or other storage means to allow for collected data to betemporarily stored, or recalled/displayed, until it can be downloaded(or uploaded) to a remote system. Alternatively, the connection betweendiagnostic device and associated microprocessor device can be wireless,using either short-range signal (such as a Bluetooth® or LAN network) ora long-range digital or cellular network to transfer data, therebyallowing the computer and the treating physician to be either local orremote. The onboard, local or remote microprocessor can record,transcribe and/or analyze specific measurements and/or enable local orremote analysis and diagnosis.

As noted above, in certain embodiments, the device housing can be“smart”, i.e., outfitted with a programmable computer chip or othercomplex microprocessing components that enables on-board programming andanalysis. Alternatively, the device may be a simplified “dummy” devicethat receives all its programming instructions from a remotemicroprocessor, such as a laptop computer, tablet or Smartphone. So asto reduce user error, in a preferred embodiment, the device housing isoutfitted with a display screen that allows the user to cycle through amenu of pre-programmed operating modes and modules, more preferablyoptions that walk the medical practitioner through the requisite set-up,initialization, measurements and/or recordation processes.

In certain preferred embodiment, the components of the diagnostic devicemay be powered by a pre-charged power source, such as one or more AA or9-volt batteries. In an alternate embodiment, the diagnostic device canutilize a rechargeable power source, for example, a rechargeablelithium-ion battery, and optionally coupled with requisite chargingaccessories such as a charging cord, adapter and/or charging cradle.

It is yet another objective of the present invention to provide a kitfor measuring selective tissue conductance, and optionally otherphysiological parameters, for the sympathetic sudomotor assessment ofcorporeal pain that includes a diagnostic device as described abovecoupled with:

-   -   one or more pre-powered or rechargeable batteries and associated        charging accessories;    -   one of more audio output devices such as wired or wireless        earphones, headphones, and/or external speakers;    -   one or more disposable sensor heads;    -   one or more memory cards or memory chips for locally storing        data on the diagnostic device;    -   one or more cables for connecting the diagnostic device of the        present invention to microprocessing device such as a laptop        computer, a tablet, smartphone, or external hard drive;    -   requisite analysis and/or report-writing software to facilitate        subject evaluation; and/or    -   written instructions to ensure proper operation.

Yet another objective of the present invention is to provide a series ofpre-programmed montages to automate measurement intake for specificinjuries and/or tissue types and ensure consistency. For example, themontage may comprise a grid or pattern of vertical and horizontal linesthat form four adjacent quadrants of equal size, each of which includesan equal number of aligned measurement sites that are mirrored inadjacent horizontal, vertical and diagonal quadrants so as to enableready comparison.

In one aspect, the present invention provides an apparatus, system andmethod that allows for the measurement, recording and analysis of skinconductance measurements to evaluating for sensory nerve pain testingand dysfunction, as well as degree of pain. As noted above, in thecontext of the present invention, readings at particular locations arecompared to normative or baseline measurements. The degree to which aparticular reading exceeds an associated “normal” reading determines notjust the presence of pain in the noted location but the degree of pain,and, by extension, the severity of the underlying injury, disease ordisorder. In preferred embodiments, the present invention utilizes theabove-noted pre-programmed montages to automate multiple readings withina particular region of the body. Results are then compared (a) betweensides along horizontal lines and (b) between proximal and distal regionsmeasured along vertical lines. By comparing across quadrants, thephysician can identify asymmetrical reading(s) and correlate thelocation of such asymmetry with the degree of pain involved and thus theseverity of any underlying injury, disease or disorder. In this manner,the subject acts as his or her own control.

In an alternate embodiment, asymmetrical locations may be identified bycomparison to (a) a subject's current readings (e.g., by comparing to amirrored bilateral equivalent); (b) a subject's prior readings (e.g.,from a previous assessment, potentially before the onset of therapy); or(c) a normative data set of “normal” and “pain” patients, optionallyfurther divided and characterized according to sex, age, injury, andbody part involved.

It is a further objective of the present invention to provide for thecreation of a database that includes a normative set of patient dataand/or individualized patient data that may be used by the medicalpractitioner to identify the presence of a particular nerve disorder,characterize its severity and/or track progress over time. In apreferred embodiment, this database enables the comparison of apre-injury baseline to a post-injury measurement to distinguish physicalinjury from psychosomatic pain. Also enabled is the comparison of painrelief afforded from different medications and/or therapies (e.g.,opioid vs. non-opioid) and the correlation of raw data/sympatheticparameters to a particular diagnosis and/or therapy.

In yet another aspect, the present invention incorporates software andprogramming to automate two-point discrimination for assessment of nerveinjury and recovery in an affected region.

These and other aspects are accomplished in the invention hereindescribed. Further objects and features of the invention will becomemore fully apparent when the following detailed description is read inconjunction with the accompanying figures and examples. However, it isto be understood that both the foregoing summary of the invention andthe following detailed description are of a preferred embodiment, andnot restrictive of the invention or other alternate embodiments of theinvention. In particular, while the invention is described herein withreference to a number of specific embodiments, it will be appreciatedthat the description is illustrative of the invention and is notconstructed as limiting of the invention.

BRIEF DESCRIPTION OF THE FIGURES:

Various aspects and applications of the present invention will becomeapparent to the skilled artisan upon consideration of the briefdescription of figures and the detailed description of the presentinvention and its preferred embodiments that follows:

FIG. 1A is a photograph depicting a top-down view of an illustrativeembodiment of a diagnostic device (100) of the present invention.

FIG. 1B is a photograph depicting a perspective view of the diagnosticdevice (100) of FIG. 1A.

FIG. 2A is a plan view of the diagnostic device (100) of FIG. 1A.

FIG. 2B is a plan view of a wired earphone that can connect to thediagnostic device (100) of FIG. 1A.

FIG. 2C is a plan view of a connecting cable that serves to connect thediagnostic device (100) of FIG. 1A.

FIG. 2D is a plan view of a pair of disposable AA batteries that serveas the power source for the diagnostic device (100) of FIG. 1A.

FIG. 3A is a side-elevational view of the underside diagnostic device(100) of FIG. 1A, with battery cover (56) removed.

FIG. 3B is a side-elevational view of the underside of the diagnosticdevice (100) of FIG. 1A, with proximal battery cover (56) attached anddistal electrode (4) removed.

FIG. 3C is an expanded view of the objects of FIG. 3A at location A.

FIG. 4 is a loop illustration of the different operating modes andutilities that may programmed into a diagnostic device of the presentinvention.

FIG. 5 depicts an illustrative display screen for a diagnostic device ofthe present invention, in “Ready” or “Manual” Mode.

FIG. 6 depicts an illustrative display screen for a diagnostic device ofthe present invention, in “Procedure” Mode.

FIG. 7 depicts an illustrative display screen for the “Review” utilityin a diagnostic device of the present invention.

FIG. 8 depicts an illustrative display screen for the “Clear” utility ina diagnostic device of the present invention.

FIG. 9 depicts an illustrative display screen for the “Time/DateSetting” utility in a diagnostic device of the present invention.

FIG. 10 depicts an illustrative display screen for the “Volume” utilityin a diagnostic device of the present invention.

FIG. 11 depicts a typical 6×6 matrix, with 6 rows and 6 columns, commonto the montage procedures of the present invention and a convention usedfor numbering of each of measurement sites.

FIG. 12 depicts the 6×6 matrix of measurement sites as well asmeasurement sequence for assessment of upper facial tissue, designatedas preset montage S01 (UPR-FACE).

FIG. 13 depicts the 6×6 matrix of measurement sites as well asmeasurement sequence for assessment of anterior neck tissue, designatedas preset montage S02 (ANT-NECK).

FIG. 14 depicts the 6×6 matrix of measurement sites as well asmeasurement sequence for assessment of chest tissue, designated aspreset montage S03 (CHEST).

FIG. 15 depicts the 6×6 matrix of measurement sites as well asmeasurement sequence for assessment of abdominal tissue, designated aspreset montage S04 (ABDOMEN).

FIG. 16 depicts the 6×6 matrix of measurement sites as well asmeasurement sequence for assessment of cervical spinal tissue,designated as preset montage S05 (C-SPINE).

FIG. 17 depicts the 6×6 matrix of measurement sites as well asmeasurement sequence for assessment of thoracic spinal tissue,designated as preset montage S06 (TH-SPINE).

FIG. 18 depicts the 6×6 matrix of measurement sites as well asmeasurement sequence for assessment of lumbosacral spinal tissue,designated as preset montage S07 (LS-SPINE).

FIG. 19 depicts the 6×6 matrix of measurement sites as well asmeasurement sequence for assessment of the anterior of the upper arms,designated as preset montage S08 (UPARM-AN).

FIG. 20 depicts the 6×6 matrix of measurement sites as well asmeasurement sequence for assessment of the posterior of the upper arms,designated as preset montage S09 (UPARM-PO).

FIG. 21 depicts the 6×6 matrix of measurement sites as well asmeasurement sequence for assessment of the anterior of the forearms,designated as preset montage S10 (FRARM-AN).

FIG. 22 depicts the 6×6 matrix of measurement sites as well asmeasurement sequence for assessment of the posterior of the forearms,designated as preset montage S11 (FRARM-PO).

FIG. 23 depicts the 6×6 matrix of measurement sites as well asmeasurement sequence for assessment of the palmar and dorsal surfaces ofthe hands, designated as preset montage S12 (HANDS).

FIG. 24 depicts the 6×6 matrix of measurement sites as well asmeasurement sequence for assessment of the anterior of the thighs,designated as preset montage S13 (THIGH-AN).

FIG. 25 depicts the 6×6 matrix of measurement sites as well asmeasurement sequence for assessment of the posterior of the thighs,designated as preset montage S14 (THIGH-PO).

FIG. 26 depicts the 6×6 matrix of measurement sites as well asmeasurement sequence for assessment of anterior of the lower legs,designated as preset montage S15 (LOLEG-AN).

FIG. 27 depicts the 6×6 matrix of measurement sites as well asmeasurement sequence for assessment of posterior of the lower legs,designated as preset montage S16 (LOLEG-PO).

FIG. 28 depicts the 6×6 matrix of measurement sites as well asmeasurement sequence for assessment of the plantar and dorsal surfacesof the feet, designated as preset montage S17 (FEET).

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS:

The present invention relates to new and improved hand-held, low-voltagediagnostic devices for measuring selective tissue conductance, andoptionally other physiological parameters, for the sympathetic sudomotorassessment of corporeal pain as well as software and hardware systemsand methods associated therewith that enable the objective evaluationand assessment of patient pain, which, in turn, can be used to identifyand characterize the underlying injury, disease or disorder anddetermine an appropriate therapy.

Although any methods and materials similar or equivalent to thosedescribed herein can be used in the practice or testing of embodimentsof the present invention, the preferred methods, devices, and materialsare now described. However, before the present materials and methods aredescribed, it is to be understood that the present invention is notlimited to the particular sizes, shapes, dimensions, materials,methodologies, protocols, etc. described herein, as these may vary inaccordance with routine experimentation and optimization. It is also tobe understood that the terminology used in the description is for thepurpose of describing the particular versions or embodiments only, andis not intended to limit the scope of the present invention which willbe limited only by the appended claims.

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which the present invention belongs. However, in case ofconflict, the present specification, including definitions below, willcontrol. Accordingly, in the context of the present invention, thefollowing definitions apply:

A. Definitions:

As used herein and in the appended claims, the singular forms “a”, “an”and “the” include plural reference unless the context clearly dictatesotherwise. Thus, for example, reference to a “molecule” is a referenceto one or more molecules and equivalents thereof known to those skilledin the art, and so forth.

The term “proximal” as used herein refers to that end or portion whichis situated closest to the user of the device, farthest away from atarget site on the subject's body. In the context of the presentinvention, the proximal end of the selective tissue conductance meterfor sympathetic sudomotor assessment of the present invention includesthe handle portion.

The term “distal” as used herein refers to that end or portion situatedfarthest away from the user of the device, closest to the a target siteon the subject's body. In the context of the present invention, thedistal end of the selective tissue conductance meter for sympatheticsudomotor assessment of the present invention includes the electrodehead.

The terms “lengthwise” and “axial” as used interchangeably herein torefer to a direction relating to or parallel with the longitudinal axisof a device. The term “transverse” as used herein refers to a directionlying or extending across or perpendicular to the longitudinal axis of adevice.

The term “lateral” pertains to the side and, as used herein, refers tomotion, movement, or materials that are situated at, proceeding from, ordirected to a side of a device.

The term “medial” pertains to the middle, and as used herein, refers tomotion, movement or materials that are situated in the middle, inparticular situated near the median plane or the midline of the deviceor subset component thereof.

As discussed above, the present invention relates to an apparatus,system and method for correlating electrical tissue parameters, such asskin conductance, with sympathetic and parasympathetic nerve function(and dysfunction) so as to provide a quantitative measurement for andsudomotor assessment of the presence and severity of corporeal pain. Ofparticular interest to the present invention is the measurement ofabsolute selective tissue conductance (STC) values. In the context ofthe present invention, the STC value corresponds to the galvanic skinresponse (GSR) or electro-dermal response (EDR), which are known to beanalogous or proportional to the expected sympathetic sudomotor activitylevel for the site being measured at a given time. By comparingindividual (absolute) STC values to other surrounding or distant (oranalogous control values), sites of STC asymmetry can be identified,assessed and characterized.

As used herein, the term “tissue” refers to biological tissues,generally defined as a collection of interconnected cells that perform asimilar function within an organism. Four basic types of tissue arefound in the bodies of all animals, including the human body and lowermulticellular organisms such as insects, including epithelium,connective tissue, muscle tissue, and nervous tissue. These tissues makeup all the organs, structures and other body contents. While the presentinvention is not restricted to any particular soft tissue, aspects ofthe present invention find particular utility in the analysis of dermaland epidermal tissues to assess nerve injury, particularly peripheralnerve damage to the neck, back, limbs and extremities. The inventionalso finds utility in the assessment of chronic or acute odontogenicand/or orofacial pain and the oral/dental disorders associatedtherewith, examples of which include, but are not limited to,pericoronitis, temporomandibular joint dysfunction (TMD), and periapicalperiodontitis (owing to apical infection or postendodontic therapy ofhigh occlusal contact).

The instant invention has both human medical and veterinaryapplications. Accordingly, the terms “subject” and “patient” are usedinterchangeably herein to refer to the person or animal being treated orexamined. Exemplary animals include house pets, farm animals, and zooanimals. In a preferred embodiment, the subject is a mammal, morepreferably a human. In that the instant invention allows for objectivecharacterization of subject pain, it finds particular utility inconnection with non-verbal human and animal subjects, including humanssuffering from autism and dementia, comatose and anesthetized subjects,patients with speaking, hearing and/or comprehension disabilities, andthe like.

The human nervous system is made up two parts: the central nervoussystem (CNS), made up of the brain and the spinal cord, and theperipheral nervous system (PNS), which consists mainly of nerves andganglia. The CNS integrates information it receives from, andcoordinates and influences the activity of, all parts of the body. ThePNS on the other hand connect the CNS to the limbs and organs,essentially serving s a relay between the brain and spinal cord and therest of the body.

The PNS is divided in the somatic nervous system, which controlsvoluntary action, and the autonomic nervous system, which controlsinvoluntary action. The autonomic nervous system (ANS) acts largelyunconsciously and regulates bodily functions such as the heart rate,digestion, respiratory rate, pupillary response, urination, and sexualarousal and is the primary mechanism in control of the fight-or-flightresponse. Autonomic functions include control of respiration, cardiacregulation (the cardiac control center), vasomotor activity (thevasomotor center), and certain reflex actions such as coughing,sneezing, swallowing and vomiting. The ANS has three branches: thesympathetic nervous system (SNS), the parasympathetic nervous system(PNS), and the enteric nervous system (ENS). Whereas the PNS isresponsible for stimulation of “rest-and-digest” or “feed and breed”activities that occur when the body is at rest, especially after eating,the primary purpose of the SNS is to stimulate the body's“fight-or-flight” response, a term that encompasses a wide range ofphysical and physiological reactions to stress and injury, fromaccelerated heart and lung action to constriction or dilation of theblood vessels to paling or flushing or perspiration.

In the context of the present invention, electrical characteristics ofliving tissue are measured, assessed and correlated to sympathetic andparasympathetic nerve function (and dysfunction). Examples of suchmeasurable electrical characteristics contemplated by the instanceinvention include, but are not limited to, skin conductance and skinresistance. It is well-accepted that moist skin is associated with theability to conduct electricity more readily than dry skin, the formerhaving a lower resistance to electrical flow. When the nerve supply tothe skin is interrupted, either in the context of a physical injury or adegenerative disease condition, skin moisture drops, conductance falls,and skin resistance levels rise.

In the context of the present invention, the use of conductance as theelectrical characteristic to be measured has a distinct advantage overthe use of resistance because the relationship between conductance andnerve function is a direct relationship rather than an inverserelationship. As such, skin conductance measurements are easier toquantify, transduce, and correlate nerve function.

As noted above, the present invention is based on the combinedprinciples of instrumentation and the electrophysiological effects ofinnervation of the sweat glands. This provides a noninvasive, painlessinstrument system for the quantitative measurement of selective tissueconductance“, which is operationally defined herein as the relativeability of biological tissue to conduct a low voltage electrical signal,which is applied for a pre-determined period of time to a selected,limited, and restricted surface area of that tissue, and which sharesthose same neuroanamatomic reflex pathways as other tests of sympatheticskin activity or regional perspiration levels.

In addition to sympathetic and parasympathetic nerve function, theelectrical measurements can be correlated to other physiologicalparameters, examples of which include but are not limited to, hemeconcentration, which, in turn, may be correlated to increased ordecreased blood flow. Furthermore the electrical measurements can becorrelated to the measurement of cell surface cytokine production asmeasured by the alternative embodiments of the device, e.g., in the formof an adaptable surface head.

The present invention contemplates the simultaneous measurement of otherphysical parameters, including, for example, temperature, pressure,oxygen saturation, glucose levels, narcotic levels, etc. Accordingly, inthe context of the present invention, the testing head of the diagnosticdevice of the present invention may incorporate additional sensingcomponents to allow for the measurement and recording of multipleparameters at once. Illustrative examples of such additional sensingcomponents include, but are not limited to, thermocouples or equivalentsensors for measuring skin temperature; thermography cameras, opticalinfrared scanners, or ultrasonic sensors transducers for deep tissuevisualization; sweat-based glucose concentration electrodes andpulse-oximeters, as well as cell surface cytokine measurement devices.

The present invention makes reference to an “electrode”, more particulara “bipolar electrode assembly” for identifying local variances in skinconductance levels as an indication of sympathetically mediated ormaintained pain. In the context of the present invention, the bipolarelectrode assembly is comprised of a pair of concentric or otherwisealigned electrode surfaces wherein one effectively functions as the“active” electrode while the other functions as the “return”. As usedherein, the term “active electrode” refers to one or more conductiveelements formed from any suitable metallic material, such as stainlesssteel, nickel, titanium, tungsten, and the like, connected, for exampleto a power supply and capable of generating an electric field. As usedherein, the term “return electrode” refers to one or more poweredconductive elements to which current flows after passing from the activeelectrode(s) back to the power source. This return electrode is locatedin close proximity to the active electrode and is likewise formed fromany suitable electrically conductive material, for example a metallicmaterial such as stainless steel, nickel, titanium, tungsten, aluminumand the like.

In order to avoid shorting, the two electrodes must be separated by asuitable non-conductive spacer fabricated from a suitable dielectricmaterials such as hard rubber joined to the electrodes via an epoxy.

In a preferred embodiment, the “active” and “return” components of thebipolar electrode assembly are concentrically situated and separated byan appropriate annular spacer. However, other shapes and configurationsare contemplated by the present invention. Accordingly, the centralcontact, the annular spacer, and the outer electrode can have any shape,such as that of a circle, oval, triangle, square, rectangle or otherregular, preferably closed polygon. The surface areas of the respectivecomponents can likewise vary, from smooth and planar to contoured,ridged or ribbed. However, it is preferred that the geometric centers ofthe respective components should be common or identical, i.e.,“concentric”.

In the context of the present invention, measured skin conductanceparameters are compared against one or more reference points to identifyareas of asymmetry. The reference point(s) for asymmetrical locationidentification may be provided by (a) the subject in real-time, e.g., amirrored bilateral equivalent (e.g., left leg vs. right leg) or adjacenttissue (e.g., upper thigh vs. lower thigh); (b) a prior reading for thesame subject (e.g., from a previous assessment, potentially before theonset of therapy); (c) readings from other similarly situated subjectsor other positive control population; and/or (d) readings from “normal”(e.g., pain-free) subjects as negative control. The present inventionrefers to “normative data sets” to be used as a comparison point toidentify relative high or low STC values, that are, in turn, associatedwith pain and/or sympathetic dysfunction. In the context of the presentinvention, “normative data” is data from a reference population thatestablishes a baseline distribution for a score or measurement, andagainst which the score or measurement can be compared. Normative datais typically obtained from a large, randomly selected representativesample from the wider population.

The present invention makes reference to a device housing that containsthe requisite power and circuitry components to enable activation of theone or more sensor head components and transduction of their respectivesignals to an output that may be correlated to pain, abnormal sensation,or sympathetic nerve dysfunction. Illustrative examples of suitablecircuitry are described in U.S. Pat. Nos. 4,697,599 and 5,897,505, thecontents of which are hereby incorporated by reference in theirentirety.

The present invention involves the collection, storage and analysis ofpatient data, including measured selective tissue conductance valuesthat finds particular utility in connection with pain evaluation andassessment. In the context of the present invention, collected data isheld in an electromagnetic or optical form for access by a computerprocessor. Illustrative examples of suitable electromagnetic and opticalstorage media include, but are not limited to, magnetic tape; magneticdisks; optical discs such as CDs, DVDs, and Blu-ray disks; flash memory;main memory (e.g., dynamic RAM); and cache memory. The present inventioncontemplates data storage at both the local level (e.g., in the devicehousing or sensor head itself, in a smartphone, tablet, laptop, desktopor LAN computer) and at the remote level (e.g., a cloud-based database).

Data collection occurs at the sensor head which, as noted above, may bemounted to and demounted from the device housing or, alternatively, maybe a separate component, optionally including its own power source andcircuitry, that can communicate with, an optionally attach to, anynumber of devices and systems, both local and remote. For example, thesensor head may comprise a small, single-function or multi-functionalelectrode that may be worn by the subject either continuously or duringperiodic monitoring sessions. Accordingly, the sensor head may beoptionally coupled with a strap, band or other support to enable properpositioning and alignment on the body.

Measurement data collected by the sensor head may be managed andprocessed on local processing and interface components, such as asmartphone or tablet application or “app”, or, alternatively, on asecure cloud server synchronized with to the smartphone app or otherprocessing component (e.g., a laptop or LAN computer).

In the context of the present invention, the associated “app” should becompatible with and operational on a wide range of phone andcomputer-based operating systems (e.g., Mac, Windows, Apple, Android,Linux, Unix, etc.) and preferably include a simple user-interface andseveral key data entry and display features such as discussed in theExamples below.

The present invention contemplates two-way communication between sensorhead and the hand-held device, smartphone, tablet, laptop, and/or remoteserver. For example, the sensor head may send raw data to the “app”,which, in turn, may analyze the data and prepare and forward a report toremote server, which, in turn, may then be reviewed by remote medicalpractitioner who then may send instructions for a particular therapyback down to the “app”. In that patient data is highly personal andsensitive, all communication is preferably encrypted prior totransmission. Encrypted data may be uploaded to the server forprocessing whenever a mobile broadband or secure Wi-Fi connection isavailable.

In the context of the present invention, the term “medical practitioner”refers to a health professional from the fields of dentistry, medicine,nursing, occupational health, and physical therapy, examples of whichinclude, but are not limited to medical doctors, physician's assistants,registered nurses, nurse practitioners and LPNs, medical technicians,occupational therapists, and the like. However, the present inventioncontemplates reliance on artificial intelligence (AI), instead of or inaddition to human practitioners, to act on the “cloud based” dataplatform for analytics, clinical, and research uses to enhance, refine,and make recommendations of therapies. Such AI systems may also be usedto identify or pre-screen for future ailments based on the data drivento the platform.

The apparatus, system and method of the present invention finds utilityin connection with “open-loop”, “semi-closed-loop” and “closed-loop”treatment and therapeutic regimens. In the context of the presentinvention, “open-loop” treatment refers to a regimen in which an apriori fixed dosage (or treatment regimen) is prescribed to a patient.In contrast, “closed-loop” treatment allows for dosages to be adjustedaccording to results obtained by laboratory analysis. The term“semi-closed loop” refers to an intermediate process having both fixedand dynamic components. Accordingly, the present invention finds utilityin connection with both open-loop/fixed protocols, e.g., wherein aparticular measurement results in the recommendation of a particularpain medicine, and closed-loop/dynamic protocols, e.g., whereinhour-to-hour or day-to-day variations in certain measurements result inrevisions to the prescribed therapy, ranging from a new dosage to a newclass of pharmaceutical to a recommendations for physical therapy orsurgical intervention.

B. Utilities of the Present Invention:

There are a number of significant real-world applications for anapparatus, system, and method that allows for the automated measurementand objective determination of not just the location but also the degreeof corporeal pain, and thus the severity of the underlying injury,disease or disorder, such as presently disclosed.

For example, the methods of the present invention, wherein measured paindata is referenced, analyzed and quantified, find utility in theassessment of nerve injuries. Accordingly, the methods of the presentinvention may be applied to the evaluation of abdominal dysfunction inadults with diabetic autonomic mesenteric neuropathy and the transaxialSTC imaging of regional abdominal dysfunction. Other applications of theSTC analysis of the present invention include:

-   -   detecting regional autonomic dysfunction in aphasic or        non-communicating nursing home residents;    -   analyzing differences in unilateral STC to discriminate among,        diagnose and treat transient ischemic attacks (“TIA”),        reversible ischemic neurological deficits, and completed        unilateral hemispheric stroke;    -   analyzing STC regional differences to discriminate among,        diagnose and treat various forms of migraine, cluster, tension,        and other headache types;    -   sympathetic tracking in wound healing with or without subsequent        development of regional pain;    -   post-traumatic evaluation of symptoms not otherwise detectable        by standard diagnostic imaging procedures.

The apparatus, system and method of the present invention also findutility as an alarm system for children with intractable nocturnalenuresis (i.e., bed wetting).

Through the methods of the present invention, an underlying pathology,whether due to injury, illness or disease, may be objectively diagnosed,treated and monitored over time to determine progress. Periodicmeasurements may allow for one therapy to be measured against another.For example, the present invention provides objective criteria forcomparing the efficacy of drug A against drug B to determine which bestaddresses a particular's subject's pain symptoms.

In addition, algorithmic analysis of baseline, bilateral and/ornormative data enables to creation of a pain index, which, in turn, ishighly valuable in determining a particular treatment protocol orregimen. The present invention further finds utility in the real-timequantification of pain, not only to determine the appropriate therapybut to discriminate legitimate pain patients from drug-seekers.

C. Illustrative Embodiments of the Present Invention:

Hereinafter, the present invention is described in more detail byreference to the Figures and Examples. However, the following materials,methods, figures, and examples only illustrate aspects of the inventionand are in no way intended to limit the scope of the present invention.For example, while the present invention makes specific reference toarthroscopic procedures, it is readily apparent that the teachings ofthe present invention may be applied to other minimally invasiveprocedures and are not limited to arthroscopic uses alone. As such,methods and materials similar or equivalent to those described hereincan be used in the practice or testing of the present invention.

EXAMPLES

The present invention provides a comprehensive system for thequantitative assessment of regional sympathetic sudomotor dysfunctionwhich is useful in the objective assessment of sympatheticallymaintained pain syndromes; a painless electrodiagnostic method requiringno sensory stimulation or subjective reports by patients; a handheld,self-powered device with an LCD display; a rapid and simple testprocedure with automatic report generation; a HHSIFDA Regulatory ClassII non-invasive device; and a sympathetic skin assessment approved byMedicare and most insurance companies for procedure reimbursement.

In illustrative embodiment an improved meter and monitoring system ofthe present invention of the inventive is presented in FIGS. 1-4. FIGS.1A, 1B, and 2A respectively depict top-down, perspective, plan views ofa diagnostic device (100) designed in accordance with the principles ofthe present invention. Device (100) includes a housing (8) fabricated ofupper (11) and lower (9) portions joined at seam (13) that togetherenclose the requisite circuitry and on-board power source. The proximalend of the device (100) is designed be held within the user's hand andthus may optionally be provided with finger flanges or recesses (notshown) to ensure a comfortable and secure grip. The distal end of thedevice (100) is characterized by a projecting sensor neck (15) andsensor head (4).

As noted in FIG. 3A, the housing may be provided with a recess (52) forreceiving one or more batteries. The battery recess may be accessed byremoving cover (56). The cover can be securely reattached by couplingcover latch (58) with mating recess clip (54).

As noted in FIG. 3B, the sensor head (4) may be detached and reattachedfrom the housing as needed. As demonstrated in FIG. 3C, attachment inthe depicted embodiment is achieved by mating the projecting pins (62)and annular groove (64) on the sensor neck (15) with correspondingaligned recesses and annular hub on the sensor head (not shown).However, it will be readily understood by the skilled artisan that theposition of the respective coordinating elements (e.g., recessed slotsand grooves that mate with assorted projecting protrusions,protuberances, tabs and splines) may be exchanged and/or reversed asneeded.

In a preferred embodiment depicted in FIG. 3C, the sensor head include apair of concentric active electrodes (2, 3) separated by an insulatingring (1). This configuration is referred to a bipolar electrode in thatits functions as both anode and cathode, “active” and “return”.

Additional features of the diagnostic device depicted in FIGS. 1A and 1Bare discussed in detail below.

The depicted device (100) uses a direct current (DC) measurementtechnique. The test current of the device (100) at the sensor head (4)is preferably a very low constant current of a maximum of 10 uAdistributed over a 300 mm² area of the preferred sensor head (4) for anaverage of a maximum of 0.03 uA/mm². As discussed in greater detailabove, this aspect of selective tissue conductance technology is knownas spatial selectivity. However, as also noted above, the DC measurementtechnique can be replaced in the inventive system with a high frequency(preferably 1-100 kHz) alternating current signal to measure the currentbetween the electrode components.

Preferred features of the inventive diagnostic device include, but arenot limited to, the following:

Measurement Range: 1-80,000 nS/cm²

Measurement Lower Limit: 1 nS/cm²

Maximum Current Density: 0.03 uA/mm² (at electrode)

Output Display: Liquid Crystal

User Interface: 6 push button switches (keys)

Audible Indicators: integral speaker (optional headphone jack)

Interface: USB

Battery: 2 disposable (non-rechargeable) AA batteries

Battery Life: 70 hours of continuous operation. About 4 months withtypical usage

Electric Shock Protection: Type B

Operation Mode: Continuous

Operating Environment: 50°-95° F. (10-35° C.), 10-90 relative humidity

Shipping and Storage Conditions: −40°-70° C., 0-90 relative humidity

Accessories: disposable electrodes; headphones; and USB cable

However, it will be readily apparent that other power sources, audiooutputs, interface schemes and the like are contemplated by the presentinvention.

The diagnostic device of the present invention may be packaged as a kitalong with various coordinating accessories such as depicted in FIGS.2B, 2C, and 2D. For example, the kit may include an external audiocomponent, such as one or more wired or wireless earphones (30),headphones or speakers (not pictured). Earphones (30) for the device(100) may be needed in locations where the ambient noise level is high.Inserting the earphone connector (32) into the corresponding jack (7) onthe device housing (8) disconnects the internal speaker. Note, thevolume may need to be adjusted using up/down keys (24, 26).

The kit may further include a data transfer cord, such as depicted inFIG. 2C. In the illustrative embodiment, the respective ends include atype-C USB connector (46) and a micro-USB connector (42) coupled bycable (44). However, as noted above, alternate connector-portconfigurations are contemplated by the present invention, examples ofwhich include, but are not limited to, firewire, HDMI, and e-SATAsystems.

The kit may further include a power source, such as a pair of disposableAA batteries (50). However, as noted above, the power source may berechargeable, for example in the form of a rechargeable battery packthat would be provided with the requisite associated charging cradle orcharging cord(s). In an alternative embodiment, the diagnostic devicemay be fitted with a DC power jack capable of receiving power from a lowvoltage DC power source. Furthermore, alternating current (AC) power maybe transformed to DC power by means of a wall-mounted transformer or 9Vwall charger. In this embodiment, no AC power reaches the sensing headitself, thereby reducing the possibility and severity of electricalshock.

As noted above, each sensor head (4) is preferably used only once. Inparticular, it is recommended that a new sensor head (4) be used on eachpatient. In a preferred embodiment, the sensor head is designed as areplaceable and disposable diode. Using a new “testing head” for eachpatient improves sensitivity, extends the life of the system and avoidsthe issues of sterilization and contamination. Accordingly, theaforementioned kit may further include multiple sensor heads. Eachsensor head may be identical or different, tailored for single parameteror multi-parameter measurement. In a preferred embodiment, each sensorhead is separately wrapped in sterile packaging.

To remove a previously used sensor head (4), hold the outer edge bythumb and fingers and turn in a counterclockwise direction. To installthe sensor head (4) onto housing (8), one should first remove it fromits sterile wrapper. The center contact of the sensor head (4) is thenplaced over pin(s) (62) and in the annular groove (64) disposed in thesensor neck (15) of housing (8) of the inventive meter 2 and turned in aclockwise direction. When first installing a new sensor head, it isrecommended that the user take a few test measurements in the “Ready”mode (described below) to ensure that the sensor head (4) is functioningproperly and to become familiar with the appropriate positioning of thesensor head against the skin. While the results are not dependent on theamount of pressure, given that the conductance readings are expressed interms of square centimeters (cm²) of surface area, it is critical thatthe entire active surface (e.g., inner and outer electrodes, 2 and 3) beplaced in contact with the skin with sufficient pressure. If theentirety of the active electrode surface is not touching the skin, thereadings will be incorrect. By the same token, while too much pressureis unnecessary, too little pressure can give rise to erroneous results.

While the illustrated embodiments depict a rigid and fixed connectionbetween sensor neck (15) and housing (8), the present inventioncontemplates a flexible and/or articulated joint couplings, ranging froma simple single plane hinge to a ball-and-socket joint that affords afull 360° range of motion. Such flexible couplings ensure completecontact with the skin, particularly over contoured portions of the bodysuch as the shoulders, knees, elbows, etc. To take measurements with thediagnostic device (100) of the present invention, one should place thesensor head (4) against the skin area to be measured, making sure theentire active surface (i.e., electrodes 2 and 3 and insulator 1) isplaced in contact with the skin. The electrode should not be rockedduring testing. Apply just sufficient pressure to ensure a good contact;too much pressure is unnecessary. Listen for the confirmation toneindicating that the test measurement is complete. This step generallytakes about one half second and no more than two seconds.

Pressing the “menu” key (10) allows the operator to scroll throughdifferent programmed operating modes and utilities in a loop, asillustrated in FIG. 4. Exemplary operating modes and utilities include,but are not limited to:

-   -   The Ready Mode (or Manual Mode) is used to make one or more        individual measurements and temporarily store the data. An        exemplary display screen (30) of the device (100) in Ready Mode        is illustrated in FIG. 5.    -   The Procedure Mode is used to make measurements according to        preset programmed montages and these can also be reviewed and        uploaded to a computer. An exemplary display screen (30) of the        device (100) in Procedure Mode is illustrated in FIG. 6.    -   The Review utility is used to recall measurements taken in the        procedure mode. An exemplary display screen (30) of the device        (100) in Review Mode is illustrated in FIG. 7.    -   The Clear utility is used to delete stored tests. An exemplary        display screen (30) of the device (100) in Clear Mode is        illustrated in FIG. 8.    -   The Time/Date setting utility is used to set the date. An        exemplary display screen (30) of the device (100) in Time/Date        Setting Mode is illustrated in FIG. 9.    -   The Volume utility is used to set the volume of the internal        speaker of the device (100), or alternatively the volume output        to an external audio source, such as the earphones (30). An        exemplary display screen (30) of the device (100) in Volume        Setting Mode is illustrated in FIG. 10.

Illustrative instructions for each of the above exemplary operatingmodes and utilities are set forth below:

Ready Mode:

The following are exemplary “Quick Instructions” in Ready Mode: First,make sure the device (100) is in Ready Mode. Second, place the distalend of the sensor head (4) against the skin and hold for half a second.Third, listen for the beep and review the measurement. Fourth, by usingthe Up and Down keys, 24 and 26, previous measurements can be reviewed.

Exemplary “Step-By-Step Instructions” for the programmed Ready Mode areas follows: First, toggle through the options by repeatedly pressing the“Menu” key (10) until the device (100) displays the “Ready Mode” asillustrated in FIG. 5. Second, after the distal end of the sensor head(4) (i.e., electrode assembly: elements 1-3) has been held against theskin for approximately one-half second, a tone indicates the completionof the measurement. Remove the sensor head (4) from the skin and the STCvalue will be displayed. Further measurements can now be performed.

Note that a Gieger type tone is also provided which is proportional tothe STC values between 0 and 100 nS/cm². Any STC values higher than 100nS/cm2 will have the same tone. The device (100) will continue to updateits clicking tone but will not the display as long as the electrode isplaced on the skin. This allows the user to use the instrument to scan abody region using the Gieger clicking tone to locate areas of highconductance.

The Ready Mode can be used to take any additional individualmeasurements by repeating Step 2. The test number assigned by the device(100) increases incrementally as additional tests are performed. In theReady Mode, the diagnostic device (100) of the present invention willretain the measured STC values until it automatically turns off. Themeasurements taken in Ready Mode can be recalled for review by using theUp or Down buttons, 24 and 26.

When the power turns off or when a new mode is selected, any datapreviously stored while in the Ready Mode will be lost. If the Menu key(10) is accidentally pressed in Ready Mode, an Exit Yes/No prompt willdisplay. If the “yes” key (26) is pressed, the test data will be lostand the device (100) will revert back to Ready Mode. If the “no” key(24) is pressed, the test can be continued.

Procedure Mode:

The Procedure Mode is used when choosing from as many as eighteen ormore pre-programmed montages that may optionally be stored in the device(100). A sample list of pre-programmed montages is provided below inTable 1. However, the present invention is not limited to this specificset of montages and thus the device (100) may periodically be updated toincorporate additional and/or modified montages as needed. In any event,the Procedure mode is useful when focusing on a certain body region sothat it is easy to do an assessment and generate a report, which willhelp in finding any abnormality. The Procedure Mode assists doctors inreviewing the results and in quickly generating an accurate report.

The following are “Quick Instructions” for the Procedure Mode. First,select a pre-programmed montage. Second, enter the Montage ID fromTable 1. Third, take a preliminary first set of three “BioCheck” values.Fourth, take an array of thirty-six STC Values of the body region to betested. Fifth, take a final three post-procedure “BioCheck” values.

Illustrative “Step-by-Step Instructions” for the programmed ProcedureMode are as follows:

-   -   1. Toggle through the options by repeatedly pressing the Menu        key (10) until the device (100) displays the Procedure Mode such        as depicted in FIG. 6.    -   2. At the top of the screen, a flashing message will appear        which contains a procedure code (e.g., S01 to S18), followed by        the abbreviated name of the body region to be tested. Table 1        below presents a list of the procedure codes for each of        eighteen pre-programmed montages. The abbreviated name of the        procedure and the full name of the region to be tested are also        provided.

TABLE I PROCEDURE CODES Preprogrammed Montages S01 UPR FACE Upper FaceS02 ANT NECK Mandible & Anterior Neck S03 CHEST Chest S04 ABDOMENAbdomen S05 C SPINE Cervical Spine S06 TH SPINE Thoracic Spine S07 LSSPINE Lumbosacral Spine S08 UPARM AN Upper Arms, Anterior View S09 UPARMPO Upper Arms, Posterior View S10 FRARM AN Forearms, Anterior View S11FRARM PO Forearms, Posterior View S12 HANDS Hands (Palmar & Dorsal) S13THIGH AN Thighs, Anterior View S14 THIGH PO Thighs, Posterior View S15LOLEG AN Lower Legs, Anterior View S16 LOLEG PO Lower Legs, PosteriorView S17 FEET Feet, (Plantar & Dorsal) S18 GRADIENT Linear Gradient (2sets of 20)

-   -   3. Use the Up or Down keys (24, 26) to select the desired        procedure, then press the Enter key (28).    -   4. After selecting the appropriate preprogrammed test, the        device (100) may prompt the entry of a procedure identification        code and then switch to the Entry Mode. This feature allows the        user to enter a file or patient identification number by        pressing the Up or Down keys (24, 26) until the value for each        of the digits has been selected. After each digit is changed        from zero to its new value, press the Enter key (28).    -   5. After entering the Identification Number, the device (100)        may prompt the user to confirm the entry.    -   6. If the Identification Number is correct, press the Yes (Up)        key (26); if incorrect, press No (Down) key (24) and re-enter        the number. Once the Identification Number has been accepted,        the ID will be stored in the test data file and maintained in        the on-board memory until downloaded or transmitted to an        external storage device. The present invention contemplates both        wired and wireless connections to local, networked or cloud        storage devices.    -   7. Now the device (100) is ready to a series of preliminary        instrument test values known as “BioCheck”. While the        illustrative examples refer to Biocheck values 1, 2 and 3, it        will be readily apparent to the skilled artisan that greater or        fewer measurements may be utilized. The BioCheck confirms that        the sensor head (4) is operating properly. In the context of the        present invention, preferred BioCheck measurements made on the        right palm, left palm, and the Mid Frontal Polar Region (i.e.,        the middle of the patient's forehead). One or more measurements        must have a positive value. If all are zero, an error message        will display and will prompt the user to check the device (100)        and repeat the procedure.    -   8. After the sensor head (4) has been held against the skin for        approximately one-half second, a tone indicates the completion        of the measurement and the measured value at the time of the        tone will be entered, thus preventing the readings from being        skewed by the ionophoresis effects which, as discussed above,        may be produced by any continued application of the DC current        to the skin after the tone. The sensor head (4) must now be        removed from the skin. The display screen (30) will display a        message asking the user to indicate whether the user accepts the        value displayed. This is a double check to confirm that the        measurement was made correctly. Press the Yes (Up) key (26) or        side auxiliary keys to accept the measurement.    -   9. If the No (Down) key (24) is pressed, the data is discarded        and a new measurement can be made. It is also possible to obtain        a valid measurement that is below the threshold of 1nS/cm². This        is observed by pressing the sensor head (4) against the skin and        not receiving a tone for an STC measurement value, and will be        entered as a zero value. Pressing the Enter key (28) will store        this value as zero and continue to the next measurement.    -   10. Before collecting the main body of the data in the Procedure        Mode, the user is advised to make BioCheck measurements of the        right palm, left palm, and Mid Frontal Polar region. The        BioCheck measurements are taken to ensure the sensor head (4) is        working before and after a test.    -   11. The main portion of each examination consists of a series of        measurements made along a pattern of an equal number of vertical        and horizontal lines, forming a grid optionally composed of        thirty-six points. As noted above, this is referred to herein as        a “Montage”. Each of measurement site is identified by its        position on one of the horizontal rows (e.g., R1 to R6) and one        of the six vertical columns (e.g., C1 to C6). The resulting name        of each site is therefore expressed in terms of row number and        column number, e.g., R1C6. Illustrative thirty-six measurement        point grids for the exemplary preprogrammed body locations        recited in Table 1 are depicted in FIGS. 11-28 and discussed in        greater below. Note, however, that while the examples make        reference to a 6×6 matrix of 36 measurement sites, other        matrices are contemplated, including both square and rectangular        grids comprised of 3-8, preferably 4-6 rows and columns. In any        measurement set, normative data from 20 points is used to        establish a sample. Accurate diagnosis of differences in data        can be statistically inferred from this N.    -   12. After a test montage is completed, the BioCheck screen will        reappear and the biocheck measurements, e.g., of the right palm,        left palm, and forehead, should be repeated.    -   13. After all of the measurements are made, appropriate for the        procedure selected, the message “Test Done” may appear at the        top of the screen (30). This message will flash alternately with        an instruction to “Press A Key”. As soon as any key is pressed,        the procedure is closed with the measurements stored and the        function of the device (100) is returned to the Procedure Mode,        in preparation for the next test session. In this regard, it is        further noted that:        -   a. The test number increases incrementally as further tests            are performed.        -   b. Tests stored in the device (100) can be reviewed on the            device, for example on display screen (30). The test will be            identified according to the date and then the patient ID            number of the test performed that day. Each day the tests            are stored sequentially. Once the tests have been uploaded            to an external computer or database, the ID Number can be            used for identification, for example a search term to            identify previous results.        -   c. If the Menu key (10) is accidentally pressed in Procedure            Mode the Exit Yes/No prompt will display. If the Yes key            (26) is pressed the present test data will be lost and the            device (100) will revert back to Procedure Mode. If the No            key (24) is pressed, the test can be continued.    -   14. After the final measurements are made, the automatic        shutdown feature of the device (100) will turn off the power        after a predetermined idle duration, typically two to three to        five minutes.

Review Utility Mode:

To recall and review the aforementioned Procedure Mode tests stored onthe device (100), the Review Utility Mode is used. Tests stored in thedevice (100) can be reviewed by identifying them according to the dateand test number.

Exemplary “Step-By-Step” instructions for the programmed Review UtilityMode are as follows:

-   -   1. Repeatedly press the Menu key (10) until the Review display        such as depicted in FIG. 7 appears.    -   2. Use Up and Down keys (24, 26) to select the correct date and        test number for the relevant procedure desired and press the        Enter key (28).    -   3. Use the Up or Down keys (24, 26) to review the test.

Clear Utility Mode:

Exemplary “Step-By-Step” instructions for the programmed Clear UtilityMode are as follows:

-   -   1. Repeatedly press the Menu key (10) until the Clear display        such as depicted in FIG. 8 appears.    -   2. Press the Yes key (26) to erase all tests performed in the        Procedure Mode.    -   3. Press the No key (24) to erase a specific test. Use the Up        and Down keys (24, 26) to select a particular test.    -   4. Press the Menu key (10) to exit

Report Preparation:

The system of the present invention contemplates a report writingsoftware which may optionally be included in the aforementioned kit fora diagnostic device of the present invention. As noted above, thediagnostic device (100) is used to assist the medical practitioner(physician, clinician, technician) in recording and analyzing thecollected data. The report writing software extracts this informationand transduces it into a consistent format in which the medicalpractitioner can enter his notes and/or impressions, including, forexample, additional aspects of the patient's physical or psychologicalpresentation, such as mood, range of motion, limitations, etc. Forexample, when the examining medical practitioner prepares a report, heor she can review the downloaded and stored procedure readings and canthen enter “Indications for Referral” or “Impressions”. If a technicianis preparing a test report, the “Indications for Referral” or“Impressions” fields can optionally be left blank so that the examiningphysician can fill in these fields.

The following is a non-exhaustive list of illustrative functions for theReport Writer Software contemplated by the present invention:

-   -   1. Downloading stored procedure readings from the device (100)        to an external device, such as a local computer. Alternatively,        the results may be imported, downloaded, copied or otherwise        transferred to a remote location, such as a remote storage        device or cloud-based database.    -   2. Preparing reports.    -   3. Saving a test report as an editable document (such as a Word        file) with an allocated filename onto a physical storage device,        such as an external hard drive, disk, or CD-ROM, or        alternatively to the aforementioned cloud database.

In a preferred embodiment, the test report may include: subject detail(patient data); indication for referral, entered by examining physician;method; result; impressions entered by examining physician; the measuredSTC values of the test; and the average value of the thirty-six STCmeasurements.

To download the collected data and test, a small USB connector, such asa mini-USB connector (42) of a USB cable (40), may be connected to theUSB port (5) of the device (100) and a larger standard USB connector,such as a type-C USB connector (46) of the USB cable (40), is connectedto the USB port on the practitioner's computer or external hard-drive.Alternatively, as noted above, the connection between diagnostic device(100) and remote storage and/or analysis device, such as a local ornetworked computer or external hard-drive or cloud database, may bewireless, e.g., over a cellular network or short-range connection suchas Bluetooth®.

An illustrative overall programmed procedure for downloading the storedprocedure measurements from the device (100) is as follows:

-   -   1. Make sure that the device (100) is in Ready mode.    -   2. Double click or otherwise activate the Report writer software        icon.    -   3. Connect the device 2 and the computer using the USB cable.    -   4. The device (100) will display the USB icon on its display        (30).    -   5. On the computer, click on the “Download from Device” button.    -   6. The computer screen will display those procedures stored in        the device (100).    -   7. To select a particular test to be downloaded, highlight the        test.    -   8. Click on the Download button (24).    -   9. Repeat steps 7 & 8 to download each test.    -   10. After downloading the tests required, click on the Return To        Main Menu button.    -   11. To select a particular test to be deleted, highlight the        test and click on the Delete button.

Illustrative step-by step instructions for using the programmedprocedure for preparing reports are as follows:

-   -   1. Click on the “New Report” button, which starts the        preparation of a final Word report.    -   2. To delete a downloaded test from the device, select the test        to be deleted and then click on “Delete the downloaded test”.    -   3. To delete all the tests downloaded from the Epi-Scan, click        on “Delete All”.    -   4. After analyzing the recorded data by clicking on “Next»” the        programmed procedure will start preparing the test in Word        format.    -   5. Click on “«Back” to see previous screens or “Return to Main        Menu” to go back to the “Choose Patient Test” Screen.    -   6. After analyzing the recorded data by clicking on “Next»>”,        the programmed procedure will automatically start preparing the        test in the Word format.

To See the “Final Reports” Prepared in Word:

-   -   1. Click on “Open Prepared Report.”    -   2. A “Device Report” Screen will appear.    -   3. A list of the prepared tests will appear in the list box.    -   4. Double click on the prepared final Word report desired.

Data Analysis:

Internal tests of function and calibration are performed automaticallyat the time of setup. However, the BioCheck function in the ProcedureMode provides a real-time test of the device (100) function while makingmeasurements on active biological tissue, i.e. glabrous skin. SinceBioCheck samples are made at sites, which are physically far from eachother (palms of the hands, forehead), the values obtained also give someinitial information about the dynamic range of regional differences insudomotor function.

Following the Procedure montage, discussed below and illustrated inFIGS. 11-28, allows for the creation of a matrix set of discretemeasurements, each corresponding to the sympathetic sudomotor levels ateach particular location. Each individual measurement reveals anabsolute selective tissue conductance (STC) value, which reflects aresult, which is analogous or proportional to the expected sympatheticsudomotor activity level for the site being measured at a given time. Inpractice, however, more valuable information can be obtained if theindividual (absolute) values are compared to other surrounding ordistant values in a relative manner. This approach allows high or lowvalues to be reviewed within the context of their spatial distributionover the whole area being tested. In such a situation, excessively highor low local values (referred to herein as “asymmetries”) may beinterpreted relative to their surrounding results.

Thus, in a preferred embodiment, the Procedure montages requirecomparison between one side of the body and the other. In any clinical,neurophysiologic or radiologic investigation of the human nervoussystem, the standards of practice are to answer the questions (a) whereis the problem and (b) what is the problem. Humans, and indeed mostanimals, exhibit bilaterally symmetry. As such, all parts of the nervoussystem generally consist of paired structures, i.e., body areas thatoccur on either side of the midline, the first step in trying tolocalize an abnormality is to determine which side of the body has theproblem. Therefore much of the analysis of data in sympathetic sudomotorassessment is based on the detection of asymmetries or differencesbetween values measured on the left and right sides.

The values commonly obtained during sympathetic skin assessment canrange widely between one part of the body and another. The main reasonfor this is that there are large differences in the relative density ofsweat glands over different body regions. High Selective TissueConductance values are often found over the palms of the hands, axillae,groin, and soles of the feet, even in normal subjects.

In addition to differences between different body regions, there arealso differences in sympathetic sudomotor level between subjects(patients). It is for reasons such as this that the most effectiveinterpretation of sudomotor levels is to use the subject as his or herown control. This means that results are compared (a) between sidesalong horizontal lines and (b) between proximal and distal regionsmeasured along vertical lines. Accordingly, the pre-programmed montagesof the present invention are designed to incorporate at least 4 adjacentquadrants. By comparing across quadrants, the physician can identifyasymmetrical reading(s) and correlate the location of such asymmetrywith the degree of pain involved and thus the severity of any underlyinginjury, disease or disorder.

Pre-programmed Montages:

Exemplary pre-programmed Montage Procedures, along with thecorresponding body parts and locations of the measurements, are shown inFIGS. 12-28. The typical 6×6 matrix, with 6 rows and 6 columns, commonto these montages, and numbering of each measurement site is illustratedin FIG. 11. For example: R2C2 is reading of location Row 2, Column 2.R6C3 is reading of location Row 6, Column 3. However, as noted above,the present invention contemplates alternative square and rectangularmatrices. The key is to divide the target area into quadrants and takean equivalent number of readings at mirrored locations within eachquadrant so as to allow the subject to be his or her own control, i.e.,wherein comparing results between sides along horizontal lines andbetween proximal and distal regions measured along vertical lines toidentify asymmetries.

In addition to the pre-programmed montage procedures illustrated inFIGS. 12-28, the present invention contemplates a montage is notrestricted to any body area. The linear method can be analyzed in blocksor using the linear gradient technique.

Although this pattern of Sympathetic Skin Assessment is included as an Stype or Standardized montage, its design is different from thoseestablished in the previous seventeen montages S01 to S17. Instead, thepresent montage (S18) is based upon an extension of the linear gradientmethod, in which measurements are made sequentially along each of twoparallel lines. Since, this specific pattern lends itself to being usedto compare (or transpose) gradients in sympathetic sudomotor activity,it is also known as the Gradient Transposition montage, or more simplyas the Gradient montage.

Data collection for this montage consists of the same three opening(BioCheck 1,2,3) and closing (BioCheck 4, 5, 6) system tests that areused in montages S01 to S17. However the active portion of theassessment process is based upon making two sets of sequentialmeasurements, located along homologous lines over each side of the body.Each of the measurement sites is referred to by a letter designating theside (L or R) and a number (01, 02, 03, etc.), indicating the positionof that site in the series.

The Gradient Montage is often used when the goal of the procedure is todetect differences in values obtained at (a) opposite sides of the bodyand (b) adjacent sites, along longer lines of measurement, such asassessing paraspinal regions or entire limbs. It can be used to measurealong lines, which run distally or proximally as long as the startpoints are indicated on the test report and the locations of each pairof test sites are homologous.

To perform this type of test, the S18 Gradient montage is selected fromthe Procedure mode. After the Identification number has been entered,the usual BioCheck 1, 2, and 3 measurements are made. Depending on theregion of the body to be tested, a series of twenty sequentialmeasurements can be made, one electrode diameter apart, along thepreviously selected line, but always beginning on the LEFT side (L01 toL20-L20). As soon as the test site R01 appears on the screen, beginmaking measurements along the same type of line on the opposite (RIGHT)side and continue at test sites R01 to R20. Complete the procedure byperforming BioCheck 4, 5, and 6 measurements.

TABLE 2 R01 L01 R02 L02 R03 L03 R04 L04 R05 L05 R06 L06 R07 L07 R08 L08R09 L09 R10 L10 R11 L11 R12 L12 R13 L13 R14 L14 R15 L15 R16 L16 R17 L17R18 L18 R19 L19 R20 L20 L—Left side R—Right side

Thus, the present invention is well adapted to carry out the objects andattain the ends and advantages mentioned above as well as those inherenttherein. While presently preferred embodiments have been described forpurposes of this disclosure, numerous changes and modifications will beapparent to those in the art. Such changes and modifications areencompassed within this invention as defined by the claims.

INDUSTRIAL APPLICABILITY

As noted previously, there is a need in the art for the quantitativeassessment of corporeal pain. The present invention addresses this needby providing an apparatus, system and method in which pain, can beevaluated and indexed to determine not only its presence and locationbut its severity, and thus the location and severity of any underlyingdisease, disorder or injury associated therewith. The quantitative painscale and database developed in the course of the present inventionfinds utility not only in the diagnosis and treatment of any underlyingor associated disorder, disease or injury but also in determining theappropriate drug and dosage regimen, in distinguishing organic pain frompsychosomatic pain and legitimate pain patients from drug seekers andopiod addicts, and in comparing the efficacy of different painmedications.

The disclosure of each publication, patent or patent applicationmentioned in this specification is specifically incorporated byreference herein in its entirety. However, nothing herein is to beconstrued as an admission that the invention is not entitled to antedatesuch disclosure by virtue of prior invention.

The invention has been illustrated by reference to specific examples andpreferred embodiments. However, it should be understood that theinvention is intended not to be limited by the foregoing description,but to be defined by the appended claims and their equivalents.

What is claimed:
 1. A device for detecting, measuring and quantifyingcorporeal pain as an diagnostic index for underlying sympathetic andparasympathetic nerve dysfunction, said device comprising: a sensor headthat includes a low voltage bipolar electrode assembly capable ofcontacting the skin of a subject at a particular target site andretrieving an absolute selective tissue conductance (STC) valueassociated with said target site, and a means for transducing andanalyzing physiological data measured by said sensor head, includingsaid absolute selective tissue conductance values obtained by said lowvoltage bipolar electrode assembly, to a scaled output correlated topain intensity; wherein: said sensor head is operatively coupled with acommand module that contains the requisite power, circuitry, andcommunication components to enable the activation of said sensor headand the recordation of said physiological data measured thereby; andsaid means for transducing and analyzing said physiological datameasured by said sensor head to a scaled output correlated to painintensity includes an algorithm that facilitates the rapid comparison ofan absolute STC value obtained from a first target site to a referenceSTC value obtained from (a) one or more second target sites on saidsubject, wherein said one or more second target sites comprise mirroredand/or bilateral equivalent(s) of said first target site; (b) priorreadings for said subject at said first target site; (c) a database ofabsolute and relative STC data obtained from pain and/or normalpain-free patients; or (d) a combination thereof; further wherein: thedegree of difference between said absolute STC value obtained at saidfirst target site and one or more of said reference STC valuecorresponds to the intensity of corporeal pain exhibited at said firsttarget site and thus the severity of an underlying sympathetic nervedysfunction associated therewith.
 2. The device of claim 1, wherein saidsensor head further includes one or more additional biosensors formeasuring one or more additional physiological parameters throughcontact with the skin at said target site(s), further wherein said oneor more additional biosensors are selected from the group consisting of:(a) thermosensors and optical infrared scanners capable of assessing theheat and temperature of the subject's skin at said target site(s); (b)sweat-based glucose, lactate and theophylline biosensors that enablenon-invasive transdermal scoring of analyte concentration in the muscletissue proximate to said target site(s); (c) pulse-oximeters that allowfor measurement of oxygen saturation levels and assess pre- andpost-flow to the target site(s); (d) ultrasonic sensors and transducersthat enable assessment of the viability and recovery of muscle tissueproximate to said target site(s).
 3. The device of claim 1, wherein saidcommand module comprises a smartphone or tablet microprocessing device.4. The device of claim 1, wherein said command module comprises ahand-held device housing and said sensor head is configured for readyattachment and detachment from said device housing, further wherein saidsensor head is mounted to said device housing by means of a flexiblecoupling that comprises an articulated, pivoting base, further whereinsaid base includes a curved or ball type surface that is pivotablyreceived in a mating socket on a distal neck portion of said devicehousing.
 5. The device of claim 4, wherein said sensor head isindependent of said command module and includes its own power supply,measurement recording, and data transmission components.
 6. The deviceof claim 4, wherein said command module power components comprise one ormore rechargeable batteries disposed within a compartment of saidhand-held device housing.
 7. The device of claim 4, wherein said commandmodule communication components comprise means for sending and receivingwireless signals to and from said sensor head.
 8. The device of claim 4,wherein said command module circuitry components include a means forapplying a high frequency AC signal to said sensor head.
 9. The deviceof claim 4, wherein said hand-held device housing further comprise aliquid crystal display, onboard microprocessor, and onboard data storagemeans to allow for collected data to be temporarily stored, recalled,analyzed and displayed until it can be downloaded or uploaded to aremote system.
 10. The device of claim 9, wherein said a means fortransducing and analyzing physiological data measured by said sensorhead, including said absolute selective tissue conductance valuesobtained by said low voltage bipolar electrode assembly, to a scaledoutput correlated to pain intensity comprises an algorithm maintained bysaid command module or said remote system.
 11. The device of claim 10,wherein said algorithm includes the step of comparing the absolute STCvalue measured at a first target site to an absolute STC value measuredat a second target site that is the bilateral mirror of said firsttarget site.
 12. A kit for detecting, measuring and quantifyingcorporeal pain and diagnosing sympathetic nerve dysfunction associatedwith said pain, said kit comprising: the hand-held diagnostic device ofclaim 4; and a plurality of said sensor heads, each in separate sterilewrappings and configured for disposable, single-use; a series ofpre-programmed montages that automate measurement of absolute STC valuesat a plurality of a neighboring target sites associated with aparticular injury and comparison of said absolute STC values to areference point to identify the presence of one or more asymmetries thatcorrelate to pain intensity; and optional report-writing software.
 13. Amethod for calculating the intensity of pain exhibited by a subject,wherein said method comprises the following steps: (a) identify a localarea of tissue to be analyzed; (b) divide said tissue area into fourquadrants; (c) using the device of claim 1, apply the entire activesurface of the sensor head to a series of aligned target sites within afirst quadrant; (d) repeat step (c) in the second, third, and fourthquadrant; (e) compare the absolute STC values for each target site andidentify one or more sites of asymmetry; (f) optionally further comparethe absolute STC value obtained at said one or more sites of asymmetryto a reference STC value obtained from (a) a prior reading for saidsubject at said identical local area; (b) a database of STC datacollected from pain and/or normal pain-free patients; or (c) acombination thereof; and (g) analyzing and transducing the degree ofdifference between the absolute STC value at said one or more sites ofasymmetry and the reference values in steps (e) and (f) to determine thepresence and calculate the intensity of corporeal pain exhibited at saidone or more sites of asymmetry within said local area of tissue.
 14. Themethod of claim 13, wherein said subject is a non-human animal.
 15. Themethod of claim 13, wherein said subject is a non-verbal human.
 16. Themethod of claim 13, wherein said pain intensity measurements are used todifferentiate legitimate pain patients from drug seekers.
 17. The methodof claim 13, wherein said method further comprises the step ofcorrelating the intensity of corporeal pain calculated in step (g) withthe presence and severity of an underlying sympathetic nerve dysfunctionassociated therewith.
 18. The method of claim 17, further comprising thestep of monitoring changes in absolute STC values at said one or moresites of asymmetry over time, before, during, and after the applicationof a first prescribed therapeutic regimen to determine the efficacy ofsaid first therapeutic regimen in treating both the subject's pain andthe underlying sympathetic nerve dysfunction associated therewith. 19.The method of claim 17, further comprising the step of monitoringchanges in absolute STC values at said one or more sites of asymmetryover time, before, during, and after the application of a secondprescribed therapeutic regimen to determine the efficacy of said secondtherapeutic regimen relative to said first therapeutic regimen.
 20. Themethod of claim 17, further comprising the step of (a) analyzingdifferences in unilateral STC to discriminate among, diagnose and treattransient ischemic attacks (“TIA”), reversible ischemic neurologicaldeficits, and completed unilateral hemispheric stroke, or (b) analyzingSTC regional differences to discriminate among, diagnose and treatvarious forms of migraine, cluster, tension, and other headache types.